According to the official website of the State Food and drug administration, recently, the first round of novel coronavirus nucleic acid detection reagents in 2022 organized by the State Food and drug administration were all covered by random tests, and the test results met the requirements. On June 9, the State Food and Drug Administration held a teleconference to further strengthen the quality and safety supervision of novel coronavirus testing reagents to further promote the system wide continuous quality and safety supervision of novel coronavirus testing reagents. The meeting emphasized that the quality and safety of novel coronavirus testing reagents and products have a direct bearing on the overall situation of epidemic prevention and control. The whole system should implement "the strictest supervision" on novel coronavirus nucleic acid testing reagents, take more resolute and effective measures, be cautious and persistent, and continue to strengthen the quality and safety supervision of novel coronavirus testing reagents. First, we will continue to do a good job in product quality supervision in a strict and meticulous manner. Drug regulatory departments at all levels should persistently grasp all kinds of regulatory work, supervise the registrants to strictly implement the corporate responsibility, and firmly adhere to the bottom line of product quality and safety. Second, we will continue to strengthen quality supervision over product development. The provincial drug regulatory departments should further strengthen the guidance on the research and development of novel coronavirus detection reagents and registration and application, urge the registrants to conscientiously perform their main responsibilities, ensure that the product research and development process is standardized, and the registration and application materials are authentic, accurate, complete and traceable. Third, we will continue to strengthen quality supervision over product production. The provincial drug regulatory departments shall continue to organize professional forces to supervise and inspect the registrants of novel coronavirus testing reagents and their entrusted production enterprises in their respective jurisdictions, pay special attention to the operation of the quality management system, and order the enterprises to immediately suspend production, recall the defective products and carry out effective disposal if they find that there are serious violations in production activities and can not guarantee the safety and effectiveness of the products. If the violation is serious, the medical device production license shall be revoked according to law, and the relevant responsible person shall be punished according to law. Fourth, we will continue to strengthen quality supervision over product operations. City and county drug regulatory departments should further strengthen the supervision and inspection of novel coronavirus testing reagent trading enterprises, and supervise the trading enterprises to organize and carry out business activities in strict accordance with laws and regulations. Fifth, we will continue to strengthen product quality supervision in the use process. The municipal and county drug regulatory departments shall, according to their responsibilities, effectively strengthen the supervision of product quality and safety in the use of novel coronavirus nucleic acid testing reagents, and carefully check whether the product qualification, purchase channel and expiration management of novel coronavirus nucleic acid testing reagents used by medical institutions meet the requirements and whether the quality is qualified. Sixth, continue to strengthen product quality supervision and sampling inspection. Carry out full coverage sampling inspection for the novel coronavirus detection reagent products produced by the registrant and the entrusted manufacturer. Seventh, we will continue to crack down on violations of laws and regulations. Illegal acts such as production and operation without permission, illegal storage and transportation, and operation and use of unregistered or expired novel coronavirus testing reagents shall be investigated and dealt with strictly, severely and quickly according to law. In case of any violation of laws and regulations involving the supervision responsibilities of other departments, timely report to relevant departments; Those suspected of constituting a crime shall be transferred to the public security organ in time; Any supervisor suspected of dereliction of duty shall be transferred to the discipline inspection and supervision organ in time. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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